Is Ublituximab approved by the US FDA?

Drugs@FDA lists 1 application product line for Ublituximab, including BRIUMVI (Prescription).

Is Ublituximab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ublituximab: Briumvi.

Are there safety signals or safety updates for Ublituximab?

US FDA: 1 entry (latest 2026-01-16).

Active substance

Ublituximab

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BRIUMVI	25 MG/ML	injectable · intravenous	TG THERAPEUTICS, INC	Prescription	28 Dec 2022

EMA European Union — centrally authorised medicines

Briumvi Neuraxpharm Pharmaceuticals S.L. · Authorised · authorised 31 May 2023 · ATC L04

Therapeutic indication (EMA)

Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Safety signals and safety-related labeling changes

US FDA 16 Jan 2026 BRIUMVI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ublituximab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.